uBiome: Ethical Lapse or Not?

Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

uBiome’s CEO, Jessica Richman, seems to me to be a great saleswoman who also excels at sounding innocent and playing the misunderstood victim in the ethical controversy surrounding her company. I think this was well illustrated in her recent guest blog in Scientific American with Dr. Zachary Apte, co-founder and Chief Scientific Officer of uBiome. The picture is a little less rosy if you look back at the origins and history of the discussions about her company’s perceived ethical lapses.

I was intending to write about uBiome before this, as I was disturbed by Richman’s appearance at TEDMED. Admittedly, I was already put off by her telling twitter handle of “@venturejessica.” Her hubris was further evidenced by the title of her TEDMED talk, “Could a citizen scientist win a Nobel Prize?” Fortunately, her talk was a bit more restrained, though still touting the potential of her as yet untested product.

Richman and Apte’s recent blog has shown that they seem to have learned little from the heated discussions about uBiome. Their business is part of the UCSF’s Quantitative Biosciences Institute start-up incubator. While they say that lawyers provided by UCSF told them that they did not require Institutional Review Board (IRB) ethics approval—something that “didn’t sound like a great system” to them—proceeding without ethical review seems to reflect a lack of understanding of basic research ethics as well as a desire for expediency over more careful volunteer protections.

Richman and Apte complain that IRBs “are provided free of charge to members of that [academic] institution” but that they would have had to pay “thousands of dollars” for an external IRB review. Welcome to the real world. At the non-academic institution where I did research for ~25 years, there were fees for review. It was accepted as a cost of doing business, an expected start-up investment cost, to cover the administrative costs of the host institution.

uBiome proclaims their innocence because they had not yet processed specimens; they were crowdfunding their project and intending to get IRB approval after that step. But their 2/17/13 e-mail solicitation in Science Citizen Newsletter states “Please sign up to get your friends or your loved ones’ microbiomes sequenced.” Their home page certainly implies benefit: “Dozens of health conditions are correlated with the microbiome — from asthma to diabetes, autism to depression, irritable bowel, Crohn’s, chronic sinusitis, heart disease, and more. We help you investigate your personal microbiome and learn how you correlate with others. For just $89, you can learn what’s in your gut, nose, mouth, skin, genitals — or, sample anything!”

Under “How it Works,” we learn that “Our online survey lets you ask and answer questions about your health, lifestyle, demographics, social connections, and more! Then you can see how you correlate with other people in our dataset.” It then states, “our team will analyze the results to explore scientific research questions such as how the microbiome influences human health and disease.”

Under FAQs, we find: “YES! You can definitely sequence your child, at any age. You will need to give your permission to have the sequencing done. If your child is over the age of 13, they will also need to give their assent (non-binding approval) as well as parental permission.” “You will be able to opt-in to make your data available to the public.”

There is, not surprisingly, a medical disclaimer, “uBiome is not a diagnostic test. However, we can give you valuable information about your microbiome that you can use to learn more about your health.” Then their site notes an upgraded kit, ubiome DELTA ^ FIVE, in which for $1,337 “you can sample all 5 areas at 5 timepoints and see how your microbiome responds to your experiments”…“we hope to provide as useful and actionable data as possible.”

Ethical concerns

uBiome (and specifically @ventureJessica) sounds dismissive of the concerns of various bloggers but fails to either note that they are well-positioned to criticize or to respond directly to the substance of their concerns. For example, DrugMonkey is an NIH-funded researcher, who wrote, “A little reminder of why we have IRBs. Did I mention it is still Black History Month?”Janet Stemwedel, aka @docfreeride, an Associate Professor of Philosophy at San Jose State University, raised other ethical and practical concerns.Nick Evans, a bioethicist, writes about dual-use research, which might have both benevolent and harmful applications, and criticizes uBiome as a cautionary tale for citizen science.DNLee, The Urban Scientist, leant a valuable perspective on the need for self-policing in citizen science.Melissa Bates, PhD, a scientist in Pediatric Critical Care Medicine at the University of Wisconsin School of Medicine and Public Health, writes about Translational Research at BoundaryLayerPhysiology.com, and is clearly well-versed in research ethics as well as a thoughtful writer. Her criticisms, which mirror mine, included:
“1) Participation in the uBiome project requires the payment of a fee.
[Typically, research participants are not charged for participation, and thus are more free to withdraw consent without any penalties.]
2) There is no clear statement about what will be done with the data or samples.
3) There is no apparent plan for how your identity will be protected.
4) It’s not clear what conflicts [of interest] the major players in the project might have.
5) The benefits you’ll receive are grossly over-stated
6) There is no statement as to what your risks of participation are.
7) Children are included, but it’s not apparent how they are protected.”
I encourage all to read the thoughtful discussion and comments in BoundaryLayer’s ethical shenanigans and final thoughts posts.

Yes, there are problems with some IRBs, whether they are associated with academic institutions or are independent, for profit, enterprises. For example the University of Minnesota’s IRB has failed in its oversight of psychiatric trials there, as I have reviewed in the Markingson case. This included having an IRB chair who stated, shockingly, that the IRB is not responsible for protecting clinical trial subjects. Even the Johns Hopkins’ IRB received scathing criticism for failures of oversight in an asthma study that led to the death of a healthy volunteer, Ellen Roche. The GAO has criticized the workloads of IRBs as being too heavy precluding thorough review. This load on IRBs is well described in Trials and Tribulations. And IRBs are subject to conflicts of interest, as I also noted. I, too, have encountered questions as to whether an IRB approval was necessary for a given project.
But having at least an attempt at ethical and independent review is an important step, as is transparency. If there are flaws in the system, we should attempt to correct them, not ignore any attempt at oversight.

On the one hand, @ventureJessica seems to attempt being head of a naive young citizen start-up; on the other hand, uBiome has used their link to UCSF for PR and to UCSF’s legal team as an excuse for not having an IRB.

What uBiome’s management seems to be missing is that their skirting the rules hurts their image and fosters mistrust and, perhaps more importantly, may hurt the citizen science movement more broadly. Rather than whining about being misunderstood and mischaracterized, they should reflect on these criticisms–most from more experienced researchers–and try to respond. As a start towards openness, I would ask that they post their consent form—or do you only get to see that after you buy a kit? It is not just IRBs that need more transparency, Jessica.

Richman and Apte’s IRB 2.0 is not a novel concept—there has been discussion about how to make IRBs more accessible to those not affiliated with academic institutions. There is likely widespread agreement that we need alternative IRBs and better standards for IRBs.

To return to the original question posed at TEDMED, “Could a citizen scientist win a Nobel Prize?”
Perhaps. But not for this.

About the Author:Judy Stone, MD is an infectious disease specialist, experienced in conducting clinical research. She is the author of Conducting Clinical Research, the essential guide to the topic. She survived 25 years in solo practice in rural Cumberland, Maryland, and is now broadening her horizons. She particularly loves writing about ethical issues, and tilting at windmills in her advocacy for social justice. As part of her overall desire to save the world when she grows up, she has become especially interested in neglected tropical diseases. When not slaving over hot patients, she can be found playing with photography, friends’ dogs, or in her garden. Follow on Twitter @drjudystone or on her website. Follow on Twitter @drjudystone.

16 Comments

Thanks for this article. Egads – don’t need to go thru ethical review, and gee, it’s too expensive to actually have valid peer review, so off we go to get our Nobel Prize!? This is yet another cautionary tale about academic institutions getting into bed with for-profit enterprises – the academics get contaminated in the search for $$.

Viewed in the light of your Dan Markingson series, I did enjoy one of Ms. Richman’s criticisms of current IRBs, “… the lack of consistency between IRBs (meaning that the University of Minnesota may approve something that the University of Wisconsin would not) …”.

I agree–and have noted–that there are problems with IRBs. But it is important to have some attempt at an outside, independent ethical review. Efforts need to be made to improve the IRB system, not abandon it.

This is a joke. This is not Tuskegee or Henrieta Lacks. They processed 0 samples before a full and comprehensive ethical review. They did not “abandon” the IRB system, and to insinuate that they did is an affront to honesty and fairness. They were not “skirtting the rules”. The standard is to receive ethical review before conducting research. They did that, and never intended of doing anything else. Would you go through full IRB approval for a project before you write the grant to fund that project? That certainly is not the standard in the field. You can talk about hypotheticals all day long but it is useless blather that impedes the dissemination of knowledge that will probably actually help improve people’s lives.

All of your concerns listed are perfectly reasonable, and are exactly the thing that the professional, 3rd party IRB would have looked at. That acreddited IRB was satisfied with the answers and approved uBiome. To try and gin up public outcry to second guess that decision means that you are the one abandoning the IRB system, not uBiome.

Making sure they got IRB approval is all fine and good, but continuing on this line of argument after they have taken the ethically responsible steps is nothing more than self-aggrandizing obstructionism.

It is customary and “standard” to obtain IRB approval for any advertising to solicit volunteers for research–not after the fact. Similarly, it appears that you cannot see a consent form unless you purchase a testing kit, which is highly inappropriate. The evasive answers about IRB on the BoundaryLayer discussion, were also disturbing. uBiome could have raised funds for IRB through their crowd-funding, rather than after-the-fact, or sought a loan if they were so confident in their product. Claiming that their research “will probably actually help improve people’s lives” is precisely the type of hype that IRBs are supposed to protect against in advertising and consent. I would also like to know what IRB approved the protocol. uBiome is all about openness in volunteer data; it would be great to see more transparency from them.

My reading of Ms. Richman’s post leads me to believe that uBiome did get their IRB approval before beginning to deliver their product. Is it your position that the IRB should have been secured prior to raising the funds for the company start-up rather than after?

Crowd funding, public involvement, non-academic institution based research and IRB access are important areas for problem solving and working together. These are areas that will affect us all. I am glad the questions are coming up because I want to know the answers too.

It seemed to me that IRB approval was reached after crowd sourcing but before data was sourced. Great topic for discussion and methodological policy setting but not to condemn someone’s project or character.

It is new ground as we never had crowd sourcing to contend with…I am shocked that the crowd funded meth lab went unquestioned but this project was targeted. Unregulated cell clinics are given major press with a lets see what happens next attitude and yet this reasonably low risk, low cost project is singled out, why? Do the big players have better lawyers?

Has anyone talked to Jessica Richman or her partners or just at her through twitter snipes like ‘full of shit’ WOW, it is like bullies on a playground.

Emotionalism, personal character attacks and not giving someone the opportunity to examine the question and to correct lapses with dignity is an unhelpful dichotomy that will hurl people into us and them corners rather than we can build together teams.

These young and innovative basic scientists are hardly on par with the ethical breaches of those you mention in this blog and yet they have been damned and painted with the same brush. It is harmful bias. This a tactic used by religious right extremists with no faith or compassion. I can’t even imagine the pain this must cause and for what? People matter and being right is not the same as doing right. Give peace and reason a chance.

How could ethical understanding or life come from this? I would hope senior mentors and research scientists would lead by example, guide with compassion and build bridges. Is there someway to turn around and start over? Humans are unlikely to share with those who use them as a punching bag and example of harm with no more assistance than a bag of should haves. I hope UBiome is big enough in heart to grow past this and not be tainted by bitterness.

Declaration: UBiome does not know me and I have no financial interests, patents etc in their organization. It might be any of us who thought of crowd sourcing funds. I hope they learn, grow and survive with integrity inspite of this.

IRB approval is supposed to be obtained for any advertising for a study. You might argue that is unnecessary, but those are the requirements. They could have done a separate fund-raising for their proposal alone to raise funding for the IRB.

This appears to be an IRBv1 / IRBv2 issue. IRBv1 presumes the existence of a commonly academic, often federally funded organization. While this is the traditional model, it is an unwarranted assumption in instances of start-ups.

It seems to me that an IRB finding relates to some proposed study – some future program – of an existing organization. While an IRB should precede the study, it seems unreasonable for it to be part of the cost of starting (crowd-funded or otherwise) a business which plans to do the study.

Dr. Stone,
Are these the same people that co-founded PDF tribute in the tragic Aaron Schwartz case to honor Aaron and his family after his suicide in the face of unreasonable and excessive legal badgering and threats? What if we could change the tradition and the future by extending answers and compassion along with correction? I know it was calming and comforting for me to see the power of PDF tribute and the peaceful solidarity as the scientific community banded together to support Aaron and open access.

It certainly makes sense that advertising be IRB approved when a health benefit is suggested. My take was they were selling the kits for personal use and were offering the option to join in observational research and data sharing for research only at a later date. If the approval was sought after it should have been but before any kits were shipped how could this be corrected without abandoning the research or destroying this groups research future? These are young enthusiastic scientists who also managed to raise 300,000 in Crowd funding to support the project. Is there some way to give them a chance to course correct with dignity?

I’m surprised to see this level of ad hominem attack published in Scientific American. I’m a physicist who is keenly interested in the current swell of support for citizen science, and while some of the SciAm posts on uBiome and IRBs have been thoughtful and well-reasoned (like Janet Stemwedel’s, and the founders’), this one probably should have had some of the personal insults edited out before publication if it wanted to make a cogent point.

I posted this before but it didn’t go through for some reason, so trying again. There is a well articulated article by the uBiome folks here in SA that came before this piece that seems to explain this in a logical way.

Calling uBiomes path to an IRB an ethical lapse is seems to me to be totally off base – they have an IRB and an approved Human Subjects protocol!

What a bitter negative article. Organisations like the IRB have the potential to quash innovation with high fees that any startup would struggle to pay. Give them the benefit of the doubt and let’s applaud innovation.

By all means have the IRB debate, but you lose credibility by attacking Jessica Richman personally. Who cares if she uses the word venture in her Twitter handle? UBiome is a venture and she is indeed venturing into new territory – hardly hubris. There seems to be some kind of personal agenda here that is obscuring the academic debate. I expect to see this his kind of b_tchiness in a schoolgirl Facebook page – not in the Scientific American. Rise above it. Play the ball, not the (wo)man.